On November 17, 2020, nine months after the start of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Lucira Health for the first COVID-19 diagnostic test for self-testing at home. The test provides rapid results. The EUA can be viewed here.
The FDA issued an EUA to Lucira Health based on the totality of scientific information available surrounding in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19. While the FDA has previously authorized at-home sample collection kits, the Lucira All-In-One Test Kit is the first test that can be self-administered and provide results at home.
Lucira's COVID-19 single-use test kit has been authorized by the FDA for individuals aged 14 and older who are suspected of having COVID-19 by their health care provider. This single-use test is authorized for home use, but it may also be used in point-of-care settings such as doctors' offices, hospitals, and emergency rooms. If an individual is under the age of 14 but is at a point-of-care setting, the test may be used on the individual, provided the sample is collected by a health care provider. Currently, the Lucira COVID-19 All-In-One Test Kit is only available by prescription.
The kit provides users with the test device, sample vial, swab, and instructions. The test requires the sample swab to be swirled in each nasal cavity five times. The swab is then placed in the sample vial, which is then placed in a test unit. A "ready" light will blink until a "positive" or "negative" green light is illuminated.
This single-use test kit offers results in 30 minutes or less, which can be read from the testing unit's light-up display. If an individual receives a positive result, the test indicated that there was a presence of the COVID-19 virus. Individuals who test positive should self-isolate and seek additional care, if necessary. If an individual receives a negative result, but experiences symptoms similar to COVID-19, they should follow up with their health care provider. The FDA indicates that negative results do not necessarily preclude an individual from having COVID-19.
As required in the EUA, a health care provider who prescribes this test is required to report all test results received from individuals to the appropriate public health authorities, in accordance with their local, state, and federal requirements. Lucira's COVID-19 All-In-One Test Kit provides instructions for how health care providers can report test results.
According to Lucira's press release, their testing kit is expected to be available in Northern California and Florida in the near future, and they plan to distribute the kit nationally by early Spring 2021 with a price tag around $50. By current estimates, between 50 and 100 million COVID-19 tests may be conducted each month in the United States, with as many as 900 million total through 2021.
This EUA will be effective until the declaration that the circumstances surrounding the justification for authorization of the emergency use of diagnostics for detection and/or diagnosis of COVID-19 is terminated. The FDA recently issued the following statement: "Today's authorization for a complete at-home test is a significant step toward FDA's nationwide response to COVID-19… We look forward to proactively working with test developers to support the availability of more at-home test options." Diagnostic testing is one of the pillars of the United States' response to the COVID-19 pandemic. The FDA continues its mission to make more of these tests available to consumers through EUAs.
